New Chapter in the European Pharmacopoeia on Multivariate Statistical Process Control
Register now for ECA's GMP Newsletter
In past September you could already read about the draft of a new Ph. Eur. chapter (5.28) regarding Multivariate Statistical Process Control (please see New Ph. Eur. chapter on statistical process control (SPC) planned). The comment period ended in September 2019. Now, this chapter has been adopted and will be published in the October 2020 issue. It is the first time that this topic is included in a pharmacopoeia. The chapter provides an introduction to the topic, but will not become legally binding. The chapter includes:
- General Introduction
- Introduction to Statistical Process Control (SPC)
- Introduction to Multivariate Statistical Process Control (MSCP)
- Theoretical background
On the website of the European Directorate for the Quality of Medicines and HealthCare (EDQM) you can find more information on this chapter under "European Pharmacopoeia: Adoption of a new general chapter on Multivariate Statistical Process Control".
Related GMP News
17.09.2025Ongoing/Continued Process Verification - The Perspective of an European GMP Inspector
10.09.2025Statistical Process Control (SPC) in a Restaurant - an universal Application
03.09.2025Revalidation - the FDA Perspective
13.08.2025Survey Results: The Use of DoE in the Pharmaceutical Industry - Part II
06.08.2025Survey Results: The Use of DoE in the Pharmaceutical Industry - Part I
30.07.2025Annex 11 Draft - First Analysis